Trabectedin and Irinotecan for Refractory Pediatric Sarcomas
- Sponsor
- Technical University of Munich
- Study ID
- NCT02509234
- Status
- Unknown
Conditions
- Recurrent Childhood Soft Tissue Sarcoma
- Recurrent Ewing Sarcoma
- Recurrent Rhabdomyosarcoma
Eligibility Criteria
- Sex
- ALL
- Age
- 10 Years - 40 Years
- Healthy Volunteers
- Not accepted
Interventions
- Combined chemotherapy with trabectedin followed by irinotecan — DRUGDay 1: Trabectedin 1,1 - 1,5 mg/m²/day i.v. Day 3-5 and 10-12: Irinotecan 30- 90 mg/m²/day p.o. or i.v.
Study Details
The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.
Key Dates
- Start date
- Feb 28, 2014
- Status verified
- Jul 2015
- Primary completion
- Jul 31, 2016
- Completion
- Jul 31, 2017
Study Design
- Enrollment
- 30 participants (estimated)
Primary Outcome Measure
Toxicity during therapy [ Time Frame: As long as patient is undergoing therapy/ 6 months ]
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